HISTORIC MILESTONE REACHED BY PHARMA OUTSOURCING COMPANY

ethica becomes the first privately-owned company to be accredited by Alion

Montreal, November 5, 2013 – ethica Clinical Research Inc. (ethica) is proud to announce that its Human Research Protection Program (HRPP) which includes the services of its subsidiary companies, Veritas IRB Inc., ethica CRO Inc. and Merita CQA Inc., has been awarded accreditation by Alion HRPP Accreditation Services (Alion). ethica is the first privately-owned company as well as the first Canadian company to be accredited by Alion.

In 2006, ethica made history by becoming the first Canadian company and first CRO in the world to be accredited by AAHRPP (Association for the Accreditation of Human Research Protection Programs); the only accrediting body at that time. Earlier this year, Alion provided the clinical research industry with an accreditation alternative by making its HRPP accreditation services more widely available.

ethica selected Alion based on its long history of oversight, its practical approach to accreditation, and its commitment to continuous improvement of its accreditation standards. These attributes were validated during the accreditation process; Alion’s review was rigorous yet void of any unnecessary rigidity, according to Martin Letendre, Managing Director of Veritas IRB.

“The human research environment is constantly evolving. To be effective, our business model and HRPP must also be dynamic processes”, stated Janice E. Parente, PhD (President of the ethica group of companies). “Alion has clear and concise business practices, policies and standards that are applied consistently. The quality and substance of the review conducted by Alion were exceptional and demonstrated a higher level of experience in and understanding of emerging trends in human research. The feedback we received from Alion was insightful and extremely valuable in improving our HRPP, further strengthening the protection of research participants in clinical research managed and overseen by our subsidiaries, ethica CRO, Veritas IRB and Merita CQA.”

Accreditation by Alion acknowledges ethica’s long-standing commitment to the protection of human research participants’ rights and welfare. As part of the accreditation process, the Alion Council on Accreditation also recognized two Exemplary Practices of ethica; the independence of Veritas IRB’s board members to approve, modify and disapprove research (Alion Standard #6) and, the excellent procedures and practices of Merita CQA for monitoring and auditing to ensure compliance and quality assessment and improvement (Alion Standard #11).

About ethica Clinical Research Inc.

ethica Clinical Research Inc. provides services to sponsors of clinical research worldwide through its wholly-owned subsidiaries. ethica CRO Inc. is a full-service Contract Research Organization (CRO) that conducts and manages ethical clinical research on drugs, biologics, medical devices, cosmeceuticals and natural health products to international clinical research sponsors. Veritas IRB Inc. is an experienced and transparent Independent Review Board (IRB) committed to ensuring the safety, rights and well-being of research participants.Merita CQA Inc. provides internal support to the corporation and expert quality assurance services and training for clinical researchers, investigators and study coordinators. For further information visit: www.ethicaclinical.com.

About the Alion HRPP Accreditation Program

Alion Science and Technology launched its accreditation services in June, 2013 due to overwhelming interest in its innovative HRPP accreditation program and progressive Standards. The Alion HRPP Accreditation program features experienced staff, a client-friendly philosophy and a flexible yet rigorous accreditation process. The Alion Council on Accreditation consists of six recognized experts in the field of human research protection and research ethics. For information about the Alion HRPP Accreditation Program email
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or visit www.AlionHRPP.com.

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Media Contact: To arrange an interview, please contact Ron Kolanitch, Corporate Director of Business Development at (514) 337-0442 ext. 212, or at
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ethica Clinical Research Inc. (ethica) is pleased to announce that it is seeking accreditation of its Human Research Protection Program (HRPP) from Alion HRPP Accreditation Services (Alion). ethica’s HRPP includes the services of its subsidiary companies, ethica CRO Inc., Veritas IRB Inc. and Merita CQA Inc.

As an established provider of clinical study management and ethics review services, ethica believes that the rights and welfare of research participants are of paramount importance in the conduct and oversight of its clinical research worldwide. HRPP accreditation by an independent, industry-recognized organization confirms that ethica’s processes ensure the respect and protection of human research participants, and that its services exceed the industry's standards.

ethica’s evaluation of accreditation vendors considered a number of relevant factors including the vendors’ accreditation experience, governance, reputation, rigor, transparency and level of resources dedicated to their accreditation programs. Not only did Alion rate highly on these criteria, but it distinguished itself by its practical, collegial approach, and its commitment to continuous improvement of the accreditation process driven by experience, client interactions and emerging trends in human research.

“We saw in Alion an accrediting body that better supports our mission, offers flexible, responsive service, and aligns with our business activities,” says Janice E. Parente, PhD (President, ethica Clinical Research Inc.). “Given the dynamic nature of the research and business environments in which we operate, we share the belief that accreditation must be an equally dynamic and evolutionary process.”

ethica made history in 2006 when its HRPP was fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), becoming the first Canadian company ever to be accredited, and the first contract research company ever to be accredited worldwide. In 2009, ethica’s HRPP was re-accredited by AAHRPP through December 2014.

About ethica Clinical Research Inc.

ethica Clinical Research Inc. provides services to sponsors of clinical research worldwide through its wholly-owned subsidiaries. ethica CRO Inc. is a full-service Contract Research Organization (CRO) providing a complete range of clinical study management, site monitoring, data management and biostatistics services. Veritas IRB Inc. is an experienced and transparent Independent Review Board (IRB) committed to ensuring the safety, rights, and well-being of research participants. Merita CQA Inc. provides expert quality assurance support, clinical research and research ethics training services, and all services related to the establishment and ongoing management of Data and Safety Monitoring Boards (DSMB). For further information visit: www.ethicaclinical.com.

Media Contact

To arrange an interview, please contact Ron Kolanitch, Corporate Director of Business Development at (514) 337-0442 ext. 212, or at
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